The Recall Desk
SevereFDA (Drugs)·D-0444-2018·Announced 2018-02-28

Pharmedium Recalls Dexamethasone Sodium Phosphate Due to Sterility Assurance Issues

Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths and packaging due to a lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. The recall is being conducted because of a lack of sterility assurance. The affected product is distributed nationwide in the United States.

The recall includes all lots of the product that remain within their expiration dates. The source text does not specify the number of units affected or the specific dates of distribution.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The source text does not provide specific contact information for the recalling firm.

The recalled product

Product
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 42 products in this recall →